Acne Defense Spot Treatment

Product NDC
57627-201
11-digit product format
576270201
Labeler code
57627
Product ID
57627-201_5dac29e0-e332-6994-e063-6394a90a8a92
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
Merle Norman Cosmetics, Inc
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-07-14
Substance
SALICYLIC ACID
Active strength
2 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Acne Defense Spot Treatment
Brand name suffix
Merle Norman
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID2 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57627-201-01Acne Defense Spot TreatmentMerle Norman14 g in 1 TUBEGEL145
57627-201-02Acne Defense Spot TreatmentMerle Norman1 in 1 CARTONGEL15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57627-201ACNE DEFENSE SPOT TREATMENT MERLE NORMAN (SALICYLIC ACID) GEL [MERLE NORMAN COSMETICS, INC]4Current NDC, Legacy NDC, 2 package rows20241010_c6296d3a-fabe-4a8f-91e8-cac2ae6ff926.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 35 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Breakout Clearing Foaming WashSALICYLIC ACIDDermalogicae55d212b-7687-47fd-86ec-f8709804dd042024-12-24WarningsExact identifier
application number: M006
BREAKOUT CLEARING BOOSTERSALICYLIC ACIDDermalogica, Inc.6a3bb679-8a03-4f0a-950e-5a40f2b5b70e2024-12-24WarningsExact identifier
application number: M006
AGE Bright Clearing SerumSALICYLIC ACIDDermalogica, Incd5291f67-3329-42c7-b9c2-9bae797ecb5b2024-12-24WarningsExact identifier
application number: M006
Maybelline Dream Pure BB Beauty BalmSALICYLIC ACIDL'Oreal USA Products Inc553bea8f-92cd-416c-8bc1-39e4ec9cfcb42024-12-23WarningsExact identifier
application number: M006
Thayers Natural Remedies Since 1847 Blemish Clearing CleanserSALICYLIC ACIDLOreal USA Products Inc4e03b29c-6d1c-473c-91b9-291a0cb523fb2024-12-23WarningsExact identifier
application number: M006
Dr Throwers Oily Skin Facial AstringentSALICYLIC ACID 2%Derma Care Research Labs, LLCd692e7e2-11c7-7b4a-e053-2a95a90ae17b2024-12-20WarningsExact identifier
application number: M006
Dr Throwers Oily Skin Facial CleanserSALICYLIC ACID 2%Derma Care Research Labs, LLCd6e59f75-cd3d-3fc4-e053-2a95a90abf4c2024-12-20WarningsExact identifier
application number: M006
Monat Acne TreatmentBENZOYL PEROXIDEMonat Global Corpf76eb53e-643d-52cf-e053-6394a90a6e8f2024-12-20WarningsExact identifier
application number: M006
Dermaharmony 10% Benzoyl Peroxide Cleansing BarBENZOYL PEROXIDED3 Development, Inc.c7083b69-fed4-d497-e053-2a95a90a1a8c2024-12-20WarningsExact identifier
application number: M006
Dermaharmony 5% Benzoyl Peroxide Cleansing BarBENZOYL PEROXIDED3 Development, Inc.c7ceae0d-3215-1f83-e053-2995a90a60bc2024-12-20WarningsExact identifier
application number: M006
Detox Drops 2% Salicylic Acid Acne TonerSALICYLIC ACIDCOSMAX USA, CORPORATION2999c85e-cb4b-719e-e063-6394a90a0f282024-12-19WarningsExact identifier
application number: M006
OXY 3 in 1 Acne PadsSALICYLIC ACIDThe Mentholatum Company5b1c8f11-3b5b-4c26-b4c1-0770d1dd823a2024-12-17WarningsExact identifier
application number: M006
Phisoderm Clear Confidence Spot TreatmentBENZOYL PEROXIDEThe Mentholatum Company2a51c80a-27e8-44d3-b06f-b2a9081c57962024-12-17WarningsExact identifier
application number: M006
Oxy 10 VanishingBENZOYL PEROXIDEThe Mentholatum Companyd499b69a-25aa-4e3d-a07e-a774bc0d65f12024-12-17WarningsExact identifier
application number: M006
OXY Volcanic Clay Acne WashSALICYLIC ACIDThe Mentholatum Companyeb2a0e0b-2ed5-4c14-8607-0b61ca48c4952024-12-17WarningsExact identifier
application number: M006
OXY Volcanic Ash Acne Face WashSALICYLIC ACIDThe Mentholatum Company6d768d3d-c1df-4a85-9c76-7f7a2ec90b2d2024-12-17WarningsExact identifier
application number: M006
Oxy 10 TintedBENZOYL PEROXIDEThe Mentholatum Company0ceee85d-dc8c-49b3-9b44-8fe60022c2432024-12-17WarningsExact identifier
application number: M006
Oxy 5 VanishingBENZOYL PEROXIDEThe Mentholatum Companyc4aa0fff-6e4a-47a8-9adc-ac2426f8292e2024-12-17WarningsExact identifier
application number: M006
Oxy 5 TintedBENZOYL PEROXIDEThe Mentholatum Company94c863f0-711a-4807-ba1f-a56c7e3f86702024-12-17WarningsExact identifier
application number: M006
Phisoderm Anti Blemish Body WashSALICYLIC ACIDThe Mentholatum Companybba14225-2970-4678-b5a1-78ed94c389d92024-12-17WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
346298salicylic acid 2 % Topical GelPSNc6296d3a-fabe-4a8f-91e8-cac2ae6ff9265
346298salicylic acid 0.02 MG/MG Topical GelSCDc6296d3a-fabe-4a8f-91e8-cac2ae6ff9265
346298salicylic acid 2 % Topical GelSYc6296d3a-fabe-4a8f-91e8-cac2ae6ff9265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57627-201-015762702010114 g in 1 TUBE14 gHistorical
57627-201-02576270201021 TUBE in 1 CARTON (57627-201-02) / 14 g in 1 TUBE (57627-201-01) 1 tube2017-07-140000-00-00NoNoCurrent